Dogwood Therapeutics, Inc. (Nasdaq: DWTX) has announced the commencement of patient dosing in its Phase 2b clinical trial, known as HALT-CINP (Halneuron® Treatment of Chemotherapy Induced Neuropathic Pain), to assess the efficacy of Halneuron® in treating neuropathic pain resulting from prior chemotherapy. The trial is expected to have its first patient dosed in the first quarter of 2025.
Halneuron® is a first-in-class, highly specific Nav 1.7 voltage-gated sodium channel inhibitor, developed as a non-opioid alternative for pain management. Previous Phase 2 clinical trials have demonstrated a statistically significant reduction in cancer-related pain among patients treated with Halneuron®, with a favorable safety profile. The drug has been evaluated in over 700 patients across Phase 1 and Phase 2 studies, showing no potential for addiction.
Unmet Need in Chemotherapy-Induced Neuropathic Pain
Chemotherapy, while effective, often leads to challenging side effects, including chronic painful neuropathy. According to R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Dogwood Therapeutics, Inc., research indicates that approximately one-third of patients treated with chemotherapeutics like taxanes and platinum drugs develop chronic painful neuropathy. Currently, there are no approved treatments specifically for chronic neuropathy, and off-label use of available analgesics is generally ineffective. Furthermore, market data suggests that a significant proportion of cancer patients are treated with opioids, highlighting the need for alternative pain management strategies.
Market Opportunity and Halneuron®'s Potential
The lead indication for Halneuron® in CINP represents a substantial unmet medical need, with an estimated market value of $1.5 billion. Greg Duncan, Chairman and Chief Executive Officer of Dogwood Therapeutics, Inc., emphasized the company's track record in developing and commercializing blockbuster medicines, including pain therapeutics like Celebrex, Lyrica, and Savella.
Dogwood Therapeutics' Broader Pipeline
Dogwood Therapeutics is focused on developing new medicines for pain and fatigue-related disorders. Their research pipeline includes a non-opioid analgesic program and an antiviral program. Halneuron® is the lead candidate in the analgesic program, targeting the reduction of pain transmission through its specific modulation of voltage-gated sodium channels. Interim data from the Phase 2 CINP study are expected in the second half of 2025. The antiviral program includes IMC-1 and IMC-2, novel fixed-dose combinations of anti-herpes antivirals and celecoxib, targeting illnesses related to herpesvirus reactivation, such as fibromyalgia and Long-COVID. IMC-1 is poised for Phase 3 development for fibromyalgia, while IMC-2 is being advanced into Phase 2b research for Long-COVID, with fatigue reduction as the primary endpoint.
